Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010882708

FEI Number

3010882708

Entity Name

NextPhase Medical Devices Mexico LLC

City/State/Country

TIJUANA Baja California, MX

Establishment Address

Tomas Alba Edison 19002, Parque Industrial Tomas Alba Edison, CP, TIJUANA Baja California 22330, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NextPhase Medical Devices LLC Mexico (Owner Number: 10046837)

Owner / Operator Contact Address

Tomas Alba Edison 19002, Parque Industrial Tomas Alba Edison, CP, TIJUANA, MX-BCN 22330, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Adapter Neonatal Disp Capnostat (1149448) SPU Adult Airway ADPTR (1149466) NEO PED DISP CO2 AA, Spacelabs (6947-00) SPU INF Airway Adapter, Philips M2536A (1020709) AIRWAY ADAPTER PED/INF NAFION (1149492) AIRWAY ADAPTER ADU/PED (1149489) SPU Neonatal AIRWY ADPTR (1149339) SPU Ped-Adu Airway Adapter (6063-00) Respironics Novametrix CapnoTrak Airway Adapter Set (1103414) AIRWAY ADAPTER ADU/PED NAFION (1149491) AIRWAY ADAPTER ADU/PED NAFION CAPNOFLEX (3173ADU-00) AIRWAY ADAPTER PED/INF CAPNOFLEX (1149490) SPU 15mm Male/Female Adptr (8935-25) SPU NEO-PED Airway Adapter (6312-00) Adult DISP CO2 AA, Spacelabs (6946-00) AIRWAY ADAPTER ADU/PED CAPNOFLEX (3172ADU-00) Adapter, 15mm SPU L Deadspace (8937-25) SPU ADU Airway Adapter, Philips M2533A (1020711) SPU PED Adult A ADPTR W MTHPC (6421-00) Adapter Adult DISP Capnostat (1149386) Respironics Novametrix CapnoTrak Airway Adapter Set (1103415) CO2 NASAL CANNULA - INFANT, M2746A (3768INF-00) CO2 NASAL CANNULA - PEDIATRIC, M2745A (3768PED-00) AIRWAY, PEDIATRIC INFANT, ZOLL LOFLO, 10 (3572INF-00) AIRWAY, ADULT PEDIATRIC, ZOLL LOFLO, 10 (3572ADU-00) CANNULA, CO2, ADU, ZOLL LOFLO, 10 (3568ADU-00) CANNULA, CO2 ORAL, PED, ZOLL LOFLO, 10 (3570PED-00) AIRWAY, DEHUM TBG, PED INF, ZOLL LOFLO, 10 (3573INF-00) CANNULA, CO2 ORAL, ADU, ZOLL LOFLO, 10 (3570ADU-00) AIRWAY, DEHUM TBG, ADU PED, ZOLL LOFLO, 10 (3573ADU-00) CANNULA, O2 CO2, PED, ZOLL LOFLO, 10 (3569PED-00) CANNULA, CO2, INF, ZOLL LOFLO, 10 (3568INF-00) CANNULA, O2 CO2, ADU, ZOLL LOFLO, 10 (3569ADU-00) CANNULA, CO2, PED, ZOLL LOFLO, 10 (3568PED-00) CANNULA, O2 CO2, INF, 10, ZOLL LOFLO (3569INF-00) CANNULA, O2 CO2 ORAL, PED, ZOLL LOFLO, 10 (3571PED-00) CANNULA, O2 CO2 ORAL, ADU, ZOLL LOFLO, 10 (3571ADU-00) BITE-BLOK SafetyNET Needle (21157-000) SafetyNET Needle (21275-000) SafetyNET Needle (18275-000) CYTRELLIS DERMAL MICRO-CORING SYSTEM CANNULA NASAL CO2 ADULT 704-0010-00 (3668ADU-00) AIRWAY, ADU-PED, SLM LOFLO (3672ADU-00) AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10 (3673ADU-00) CANNULA, NASAL, CO2/O2 ADU, 704-0014-00 (3669ADU-00) AIRWAY ADAPTER KIT, PED/INF, 704-0024-00 (3672INF-00) CANNULA NASAL/ORAL CO2/O2 ADU 704-0020-00 (3671PED-00) AIRWAY ADAPTER PED/INF NAFION 704-0026-00 (3673INF-00) SAMPLE LINE MALE LUER 704-0027-00 (3674-00) CANNULA NASAL CO2/O2 PED 704-0016-00 (3669PED-00) CANNULA NASAL CO2 PED 704-0012-00 (3668PED-00) CANNULA NASAL CO2/O2 INF 704-0015-00 (3669INF-00) CANNULA NASAL/ORAL CO2 ADU 704-0017-00 (3670ADU-00) CANNULA, NASAL/ORAL, CO2/O2 ADU, 704-0020-00 (3671ADU-00) SAMPLE LINE MALE LUER NAFION 704-0028-00 (3675-00) LoFlo CO2 Sampling Cannula (1149484) LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL (3468INF-00) LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL (3470ADU-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL (3469INH-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL (3469ADH-00) LoFlo CO2 Sampling Cannula (1149476) LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL (3471ADU-00) LoFlo CO2 Sampling Cannula (1149478) LoFlo CO2 Sampling Cannula (1149435) LoFlo Sampling Line Kit w/Dehumidification Tubing (1149495) LoFlo Airway Adapter Kit ADULT/PEDIATRIC (3472ADU-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL (3470ADH-00) LoFlo SAMPLING LINE KIT w/Dehumidification Tubing (3475-00) LoFlo CO2 Sampling Cannula PEDIATRIC NASAL (3468PED-00) LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL (3473INF-00) LoFlo SAMPLING LINE KIT (3474-00) LoFlo Airway Adapter Kit INFANT/NEONATAL (3472INF-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL (3468INH-00) Sample Line-Female Luer Connector (3476-00) LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL (3469PED-00) LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL (3471PED-00) LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric (3473ADU-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL (3471ADH-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL (3471PEH-00) LoFlo Sampling Line Kit (1149494) LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL (3469ADU-00) LoFlo CO2 Sampling Cannula (1149474) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL (3469PEH-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL (3468PEH-00) LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL (3469INF-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL (3470PEH-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL (3468ADH-00) LoFlo CO2 Sampling Cannula ADULT NASAL (3468ADU-00) LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL (3470PED-00) CANNULA, NASAL/ORAL CO2/O2 PEDIATRIC (1149488) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 ORAL NASAL CANNULA (1105099) CANNULA NASAL CO2/O2 PED CAPNOFLEX (3169PED-00) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 NASAL CANNULA (1103412) INFANT NASAL CO2/O2 CANNULA (3169INF-00) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 NASAL CANNULA (1103411) CANNULA, NASAL/ORAL, CO2, ADULT, CAPNOFLEX (1149484) RESPIRONICS NOVAMETRIX CAPNOTRAK O2 DELIVERY EXTENSION LINE (1105137) CANNULA, NASAL CO2/O2 INFANT (1149482) RESPIRONICS NOVAMETRIX CAPNOTRAK WATER FILTER ASSEMBLY (1103416) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 ORAL NASAL CANNULA (1105098) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 ORAL NASAL CANNULA (1105100) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 NASAL CANNULA (1103413) PEDI NASAL/ORAL CO2 ADU CANNULA CAPNOFLEX (3171PED-00) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 SAMPLING EXTENSION LINE (1105136) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 NASAL CANNULA (1103410) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 ORAL NASAL CANNULA (1105135) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 NASAL CANNULA (1103408) CANNULA NASAL CO2/O2 ADULT CAPNOFLEX (3169ADU-00) RESPIRONICS NOVAMETRIX CAPNOTRAK DEHUMIDIFICATION TUBING (1103417) CANNULA, NASAL/ORAL CO2/O2 ADULT (1149379) CANNULA, NASAL CO2/O2 PEDIATRIC (1149483) CANNULA NASAL CO2/O2 ADULT (1149480) CANNULA NASAL/ORAL CO2/O2 ADU CAPNOFLEX (3171ADU-00) RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 NASAL CANNULA (1103409) PUMP, DISPOSABLE SUBASSEMBLY (PMI-SUB-15-380) VALVE TUBING SET (PMI-SUB-15-381) CVA130 - Halo 13mm Closed Vial Adaptor CSA100 - Halo Closed Syringe Adaptor CVA280 - Halo 28mm Closed Vial Adaptor CVA200 - Halo 20mm Closed Vial Adaptor SafetyNET Needle (18275-000) SafetyNET Needle (21157-000) SafetyNET Needle (21275-000)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2014-05-20
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-09-17
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-10-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-10-05
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2014-05-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2021-02-12
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2023-12-12
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-09-21
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-02-27
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-08-06
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2026-02-24
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2026-02-24
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2026-02-24
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2026-02-24
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2021-06-28
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-02-12

Official Correspondent

James Bennett

US Agent Details

James G Bennett Business: NextPhase Medical Device, LLC Email: jbennett@arterexmedical.com Phone: (901) 6878811

Related Public Records

Same Entity

NextPhase Medical Devices LLC Mexico

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010882708. Last updated year: 2026. Please use registration number 3010882708 when referencing this establishment in official correspondence.